Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular DiseasePhase 4NCT03770312
Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
A Phase 4 study testing Low intensity statin and Moderate intensity statin in people with Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease
- What is being tested?
- Low intensity statin and Moderate intensity statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2020to 16 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals who have been diagnosed with cancer within the last 5 years.
- Individuals who have high level of serum ALT (>2 upper normal limit).
- Individuals who have serum creatinine ≥2 mg/dL.
- Individuals who have been diagnosed with cardiovascular disease (>50% stenosis of coronary artery on imaging study, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, or myocardial infarction).
- Individuals who have been diagnosed with peripheral artery disease (>50% stenosis of peripheral artery on imaging study, or ankle brachial index <0.9 or ≥1.3).
- Individuals who have been diagnosed with uncontrolled hyperthyrodism or hypothyroidism.
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- Individuals who are taking drug that can interact with statin.
- Individuals who have physical disability to live daily life.
- Individuals with genetic disorders such as galactose intolerance (including preparations containing lactose)"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
Sang-Hak Lee, MD, 82-2-2228-8460, SHL1106@yuhs.ac
About this study
One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals. Since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. However, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals.
This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovacsular disease in elderly individuals.
Read the detailed description
This study is a multicenter, prospective, randomized clinical trial evaluating the safety of low-intensity statins versus moderate-intensity statins in the primary prevention of cardiovascular disease in elderly patients aged 70 years or older without cardiovascular disease. The patient recruitment period is 2 years, with a 6-month follow-up period (a 4-year follow-up is optional).
Individuals deemed eligible through screening will be randomly assigned in a 1:1 ratio to either the rosuvastatin 2.5mg or rosuvastatin 10mg group. After randomization, subjects will visit at 3 and 6 months for scheduled blood tests, physical examinations, and questionnaires regarding muscle symptoms. After 6 months, subjects may optionally continue routine primary cardiovascular disease prevention care for a total of 4 years of follow-up.
- Being tested
- Low intensity statin, Moderate intensity statin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity statinDrug
Use of low intensity statin for primary prevention of cardiovascular disease.
Moderate intensity statinDrug
Use of moderate intensity statin for primary prevention of cardiovascular disease.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity statin group | Active comparator | Taking low intensity statin Receives: Drug: Low intensity statin |
| Moderate intensity statin group | Active comparator | Taking moderate intensity statin Receives: Drug: Moderate intensity statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
- They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.
- These symptoms have persisted for at least 2 weeks.
- The symptoms resolve within 2 weeks of stopping the study drug.
- The symptoms reoccur within 4 weeks of restarting the medication.
Measured: 3 months
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
- They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise.
- These symptoms have persisted for at least 2 weeks.
- The symptoms resolve within 2 weeks of stopping the study drug.
- The symptoms reoccur within 4 weeks of restarting the medication.
Measured: 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
Measured: 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
Measured: 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Measured: 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Measured: 6 months
Secondary outcomes (1)
Clinical outcomes
Major adverse cardiovascular events, defined as the composite endpoint comprised of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, TIA, coronary revascularization (PCI or CABG), or hospitalization for unstable angina during extended follow-up up to 48 months.
All adverse events during 6 months.
Measured: 4 years for MACE. 6 months for all adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start5 Mar 2020
- Primary completion16 Jan 2026 (estimated)
- Study completion16 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 724 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770312
- Sponsor's protocol ID
- 4-2019-1219
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2018
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >70 Years: the SCOPE-70 RCT Study
- ClinicalTrials.gov ID
- NCT03770312
- Acronym / sponsor ID
- 4-2019-1219
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 724 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 16 Jan 2026 (estimated)
- Study completion
- 16 Jan 2026 (estimated)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals. Since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. However, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals.
This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovacsular disease in elderly individuals.
Detailed description
This study is a multicenter, prospective, randomized clinical trial evaluating the safety of low-intensity statins versus moderate-intensity statins in the primary prevention of cardiovascular disease in elderly patients aged 70 years or older without cardiovascular disease. The patient recruitment period is 2 years, with a 6-month follow-up period (a 4-year follow-up is optional).
Individuals deemed eligible through screening will be randomly assigned in a 1:1 ratio to either the rosuvastatin 2.5mg or rosuvastatin 10mg group. After randomization, subjects will visit at 3 and 6 months for scheduled blood tests, physical examinations, and questionnaires regarding muscle symptoms. After 6 months, subjects may optionally continue routine primary cardiovascular disease prevention care for a total of 4 years of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity statin group | Active comparator | Drug: Low intensity statinTaking low intensity statin |
| Moderate intensity statin group | Active comparator | Drug: Moderate intensity statinTaking moderate intensity statin |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Individuals who have been diagnosed with cancer within the last 5 years.
- Individuals who have high level of serum ALT (>2 upper normal limit).
- Individuals who have serum creatinine ≥2 mg/dL.
- Individuals who have been diagnosed with cardiovascular disease (>50% stenosis of coronary artery on imaging study, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, or myocardial infarction).
- Individuals who have been diagnosed with peripheral artery disease (>50% stenosis of peripheral artery on imaging study, or ankle brachial index <0.9 or ≥1.3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity statinUse of low intensity statin for primary prevention of cardiovascular disease. | Drug | Low intensity statin group |
| Moderate intensity statinUse of moderate intensity statin for primary prevention of cardiovascular disease. | Drug | Moderate intensity statin group |
Primary outcome
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
Time frame: 3 months
1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. 2. These symptoms have persisted for at least 2 weeks. 3. The symptoms resolve within 2 weeks of stopping the study drug. 4. The symptoms reoccur within 4 weeks of restarting the medication.
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS.
Time frame: 6 months
1. They report new or increased myalgia, cramps, or muscle aching, unassociated with recent exercise. 2. These symptoms have persisted for at least 2 weeks. 3. The symptoms resolve within 2 weeks of stopping the study drug. 4. The symptoms reoccur within 4 weeks of restarting the medication.
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
Time frame: 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form Brief Pain Inventory (BPI-SF).
Time frame: 6 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 3 months
Statin associated muscle symptoms (SAMS) - Statin associated muscle symptoms are judged using the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 6 months
1 secondary outcome
Clinical outcomes
Time frame: 4 years for MACE. 6 months for all adverse events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low intensity statin and Moderate intensity statin in people with Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statin associated muscle symptoms (SAMS) -If all of the following occur, it is defined as SAMS. (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.